83027-0072 NDC - BOWEL SODE (ASCARIS LUMBRICOIDES, BORRELIA BURGDORFERI, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, ENTEROBIUS VERMICULARIS, GIARDIA LAMBLIA, HELICOBACTER PYLORI, PROTEUS (VULGARIS), TRICHINELLA SPIRALIS, ENTEROCOCCUS FAECALIS, TAENIA SAGINATTA, TAENIA SOLIUM, ADENOVIREN NOSODE, CAMPYLOBACTER JEJUNI, CLOSTRIDIUM PERFRINGENS, DYSENTERY BACILLUS, CLOSTRIDIUM DIFFICILE, ENTAMOEBA HISTOLYTICA)

Drug Information

Product NDC: 83027-0072
Proprietary Name: Bowel Sode
Non Proprietary Name: Ascaris Lumbricoides, Borrelia Burgdorferi, Botulinum, Colibacillinum Cum Natrum Muriaticum, Enterobius Vermicularis, Giardia Lamblia, Helicobacter Pylori, Proteus (Vulgaris), Trichinella Spiralis, Enterococcus Faecalis, Taenia Saginatta, Taenia Solium, Adenoviren Nosode, Campylobacter Jejuni, Clostridium Perfringens, Dysentery Bacillus, Clostridium Difficile, Entamoeba Histolytica
Active Ingredient(s): 16 [hp_X]/mL ASCARIS LUMBRICOIDES; 16 [hp_X]/mL BORRELIA BURGDORFERI; 12 [hp_C]/mL CAMPYLOBACTER JEJUNI; 16 [hp_X]/mL CLOSTRIDIUM BOTULINUM; 32 [hp_C]/mL CLOSTRIDIUM DIFFICILE; 18 [hp_C]/mL CLOSTRIDIUM PERFRINGENS; 32 [hp_C]/mL ENTAMOEBA HISTOLYTICA; 16 [hp_X]/mL ENTEROBIUS VERMICULARIS; 20 [hp_X]/mL ENTEROCOCCUS FAECALIS; 16 [hp_X]/mL ESCHERICHIA COLI; 16 [hp_X]/mL GIARDIA LAMBLIA; 16 [hp_X]/mL HELICOBACTER PYLORI; 12 [hp_C]/mL HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; 16 [hp_X]/mL PROTEUS VULGARIS; 18 [hp_C]/mL SHIGELLA DYSENTERIAE; 8 [hp_C]/mL TAENIA SAGINATA; 8 [hp_C]/mL TAENIA SOLIUM; 16 [hp_X]/mL TRICHINELLA SPIRALIS
Administration Route(s): ORAL
Dosage Form(s): SPRAY
Pharmacy Class(es): Actively Acquired Immunity [PE]; Live Human Adenovirus Type 4 Vaccine [EPC]; Vaccines; Adenovirus [Chemical/Ingredient]; Vaccines; Live; Unattenuated [Chemical/Ingredient]

Labeler Information

Field Name	Field Value
Labeler Name:	Nutritional Specialties, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	9/15/2023
End Marketing Date:	9/20/2028

Package Information

No.	Package Code	Package Description	Billing Unit
1	83027-0072-1	60 mL in 1 BOTTLE, SPRAY (83027-0072-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	83027-0072	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAME	Bowel Sode	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Ascaris Lumbricoides, Borrelia Burgdorferi, Botulinum, Colibacillinum Cum Natrum Muriaticum, Enterobius Vermicularis, Giardia Lamblia, Helicobacter Pylori, Proteus (Vulgaris), Trichinella Spiralis, Enterococcus Faecalis, Taenia Saginatta, Taenia Solium, Adenoviren Nosode, Campylobacter Jejuni, Clostridium Perfringens, Dysentery Bacillus, Clostridium Difficile, Entamoeba Histolytica	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SPRAY	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	9/15/2023	This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE	9/20/2028	This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
LABELER NAME	Nutritional Specialties, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ASCARIS LUMBRICOIDES; BORRELIA BURGDORFERI; CAMPYLOBACTER JEJUNI; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM PERFRINGENS; ENTAMOEBA HISTOLYTICA; ENTEROBIUS VERMICULARIS; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; GIARDIA LAMBLIA; HELICOBACTER PYLORI; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; PROTEUS VULGARIS; SHIGELLA DYSENTERIAE; TAENIA SAGINATA; TAENIA SOLIUM; TRICHINELLA SPIRALIS	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	16; 16; 12; 16; 32; 18; 32; 16; 20; 16; 16; 16; 12; 16; 18; 8; 8; 16
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
PHARM CLASSES	Actively Acquired Immunity [PE], Live Human Adenovirus Type 4 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]

Drug Information

Labeler Information

Package Information

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